Device product
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
Z-1196-2017
Product summary
- Event
- Event 76292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 boxes
- Official record key
device-enforcement:Z-1196-2017
Official wording
Reason: The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Code information: lots: 11158857
Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Derived failure modes
-
Sterility assurance
package of the blister that may compromise the sterility